Alternatively the experts who evaluated the BLA evidence submitted still assessed it as being too unreliable to endorse Remestemcel as a treatment. They are professionals and their job is to examine the details and make a judgement and a recommendation. That's being fair to all applicants. The CRL identified the deficiencies and recommended what Mesoblast needed to do to rectify them. But it's not intended to give detailed instructions on how to do that.
CEO Itescu needs to go, page-145
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